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Completed

NCT Number: NCT06362759

A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP

This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 (also known as pacibekitug) in participants with chronic kidney disease and elevated hs-CRP.

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Key information

Conditions

Chronic Kidney Diseases C-reactive Protein Chronic Disease Chronic Kidney Insufficiency Chronic Renal Diseases Chronic Renal Insufficiency Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications High Sensitivity C-Reactive Protein Hs-CRP Kidney Diseases Kidney Insufficiency, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases hsCRP

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site - 0101, Birmingham, Alabama, United States

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About this study

Previous clinical studies have suggested that IL-6-driven inflammation plays a key role in the pathogenesis of cardiovascular diseases including atherosclerotic cardiovascular disease (ASCVD) and heart failure. This Phase 2 study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006, a fully human monoclonal antibody against IL-6. TOUR006 binds the IL-6 cytokine and inhibits downstream IL-6 signaling, thereby reducing the pharmacodynamic marker, hs-CRP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years at time of ICF signature.
  • Serum hs-CRP level ≥2.0 mg/L and <15 mg/L
  • Diagnosis of chronic kidney disease, eGFR ≥15 and <60 mL/min/1.73 m2 or eGFR ≥60 mL/min/1.73m2 and UPCR>200 mg/g
  • Received COVID-19 vaccine at least 30 days prior to the Screening visit, per participant verbal attestation.
  • Agreement to comply with contraception and reproduction restrictions

Exclusion criteria

  • Clinical evidence or suspicion of active infection
  • Current or recent COVID-19 infection within 30 days
  • Serious infection within 6 months or more than 1 such episode within 18 months
  • Any history of a serious opportunistic infection within 18 months
  • Known history of immunodeficiency
  • History of gastrointestinal ulceration or perforation within 12 months
  • History of active diverticulitis, active inflammatory bowel disease, or GI abscess within 12 months
  • History of GI bleeding requiring hospitalization and/or transfusion within 6 months
  • New York Heart Association Class III or IV congestive heart failure and/or hospitalization for heart failure exacerbation within 6 months
  • Acute coronary syndrome, stroke, transient ischemic attack, or other thrombotic or thromboembolic event, or arterial revascularization procedure within 6 months

Treatment and study plan

TOUR006 - 50 MG

Drug

TOUR006 50 MG

Other names: Pacibekitug 50 MG

TOUR006 - 25 MG

Drug

TOUR006 25 MG

Other names: Pacibekitug 25 MG

TOUR006 - 15 MG

Drug

TOUR006 15 MG

Other names: Pacibekitug 15 MG

Placebo

Other

Placebo

Primary outcomes

  1. Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90

    Time frame: Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.

    Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 90. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 90 visits (approximately 60 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.

Secondary outcomes

  1. Proportion of Participants With Time-averaged Hs-CRP < 2 mg/L (90 Days)

    Time frame: Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.

    Proportion of participants with time-averaged hs-CRP < 2 mg/L (90 Days)

  2. Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 180

    Time frame: Baseline through 180 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.

    Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 180. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 180 visits (approximately 150 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.

  3. Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006

    Time frame: Baseline through Day 365

    Mean trough serum concentrations (ng/mL) of TOUR006 at Days 30, 60, 90,120, 150, 180, 240, 300, and 365. On dosing visits (BL and Day 30, 60, 90, 120, and 150 visits), PK samples were collected pre-dose. PK blood samples were collected on Study Days 180, 240, 300, and 365 at approximately the same time as the pre-dose samples were collected on previous dosing visits.

  4. Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD

    Time frame: Baseline through Day 365.

    Evaluates the percentage of participants with treatment emergent adverse events (AE), which includes serious and nonserious AEs. Treatment-emergent is defined as AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants.

  5. Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD

    Time frame: Baseline through Day 365.

    Evaluates the percentage of participants with serious treatment emergent adverse events. Treatment-emergent is defined as AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants.

Sponsors and collaborators

Lead sponsor

Tourmaline Bio, Inc., a Novartis Company

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Quarterly and Monthly TOUR006 in Participants With Chronic Kidney Disease and Elevated High-Sensitivity C-Reactive Protein

Acronym: TRANQUILITY

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 12, 2024
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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